BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    MDR report key: 2120321 · Received June 2, 2011

    Report

    Report Number
    1820334-2011-00314
    Event Type
    Injury
    Date Received
    June 2, 2011
    Report Date
    May 3, 2011
    Manufacturer
    COOK, INC.
    Product Code
    MIH
    PMA / PMN Number
    P020018
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INFECTION IS LABELED IN THE IFU. (B)(4) EXPLANT IS LABELED IN THE IFU. EVENT EVAL: NO PRODUCT OR IMAGES WERE PROVIDED TO ASSIST IN THIS INVESTIGATION. THE ZENITH DEVICE HAS COMPLETED DESIGN CONTROL REQUIREMENTS SHOWING THE DEVICE MEETS PREDETERMINED REQUIREMENTS AND THAT THE REQUIREMENTS MEET THE NEEDS OF THE USER. AN IFU IS SHIPPED WITH EACH DEVICE LISTING THE INDICATIONS FOR USE, WARNINGS AND PRECAUTIONS, CONTRAINDICATIONS, AND THE PROPER DEPLOYMENT SEQUENCE. ADDITIONALLY, THE IFU STRESSES THE IMPORTANCE TO MINIMIZE HANDLING OF THE CONSTRAINED ENDOPROSTHESIS DURING PREPARATION TO DECREASE THE RISK OF CONTAMINATION AND INFECTION. PTS WITH A SYSTEMIC INFECTION MAY BE AT INCREASED RISK OF ENDOVASCULAR GRAFT INFECTION. COOK INC HAS PROCEDURES IN PLACE TO MONITOR AND CONTROL THE MFG ENVIRONMENT. SPECIFICALLY FOR THE ZENITH FAMILY OF PRODUCTS, BIOBURDEN AND ENDOTOXIN LEVELS ARE TESTED QUARTERLY. THE COMPLAINT EVENT WAS REPORTED IN AN ARTICLE PUBLISHED FROM THE MIDWESTERN VASCULAR SURGICAL SOCIETY. DEVICE INFO (PART AND LOT NUMBER) WAS NOT PROVIDED. THE DEVICE WAS EXPLANTED 80 MONTHS POST INITIAL REPAIR. THE PT HAD A UTI, WITH THE FIRST OF THREE EPISODES OF BACTEREMIA STARTING 1 YEAR BEFORE PRESENTING WITH BACK PAIN AND FEVER. THE PT WAS ON ANTIBIOTICS PRIOR TO EXPLANTATION TO TREAT REMOTE INFECTIONS. AN AORTIC-ENTERIC FISTULA (AEF) WAS DISCOVERED AT EXPLANTATION AND CULTURES WERE POSITIVE (B)(6). BY REPORT, THE PT TOLERATED THE PROCEDURE. THE ARTICLE INDICATES THAT REMOTE INFECTIONS MAY HAVE CONTRIBUTED TO THE GRAFT INFECTION. IN ADDITION, PRESENCE OF THE AEF MAY BE ANOTHER CONTRIBUTING FACTOR. HOWEVER, WITHOUT ADD'L DATA AND A TIMELINE OF EVENTS IT IS DIFFICULT TO DETERMINE CAUSALITY. WE WILL NOTIFY THE APPROPRIATE INTERNAL PERSONNEL OF THE EVENT AND CONTINUE TO MONITOR FOR SIMILAR COMPLAINTS. THE RISK ASSOCIATED WITH THIS FAILURE MODE WAS EVALUATED PER QUALITY ENGINEERING RISK ASSESSMENT (QERA) AND THE RISK ASSOCIATED WITH THE FAILURE MODE WILL REMAIN AT AN ACCEPTABLE LEVEL WITH THE INCLUSION OF THE EVENT. RISK MITIGATION IS NOT REQUIRED AT THIS TIME.

    Description of Event or Problem · 1

    THE FOLLOWING WAS REC'D THROUGH A JOURNAL ARTICLE, (GRAFT INFECTION AFTER ENDOVASCULAR ABDOMINAL AORTIC ANEURYSM REPAIR, FROM THE MIDWESTERN VASCULAR SURGICAL SOCIETY; JOURNAL OF VASCULAR SURGERY, J.JVS.2010.11.111); (PT 1 REPORTED UNDER 1820334-2011-00312, PT 2 REPORTED UNDER 1820334-2011-00543, PT 3 REPORTED UNDER 1820334-2011-00313. (METHODS) THE MED RECORDS OF (B)(6) OPEN AND ENDOVASCULAR AORTIC PROCEDURES WERE QUERIED FROM (B)(6) 2000 TO (B)(6) 2010. THE CASES WERE REVIEWED FOR PRIOR AORTIC PROCEDURES, PROSTHETIC IMPLANTS AND CTIOLOGY OF CURRENT OPEN PROCEDURE. DEMOGRAPHICS, OPERATIVE DETAILS AND PERIOPERATIVE COURSES WERE DOCUMENTED. (RESULTS) NINE PTS (1 WOMAN) WITH A MEAN AGE OF (B)(6) HAD AN EVAR THAT LATER REQUIRED AN OPEN PROCEDURE FOR EXPLANTATION AND SURGICAL REVISION FOR SUSPECTED INFECTION. ALL GRAFTS WERE EXPLANTED THROUGH A MIDLINE TRANSPERITONEAL APPROACH, WITH A MEAN TIME TO EXPLANT OF 33 MONTHS. THE EXPLANTED ENDOGRAFTS INCLUDED 4 ZENITH (COOK, BLOOMINGTON, NI). PT 3 HAD A HIGH FEVER, CHILLS AND NIGHT SWEATS FOR APPROX 1 MONTH. THIS PT PRESENTED WITH FEVER OF 102.4 DEGREES FAHRENHEIT, BUT NO OTHER SIGNS OF SEVERE SEPSIS. PT 9 PRESENTED WITH SEVERE BACK PAIN RADIATING DOWN HER LEG AND FEVER OF 103 DEGREES FAHRENHEIT, HER THIRD EPISODE BACTEREMIA IN THE PRIOR YEAR. PT 9 WAS A CURRENT SMOKER AND PTS 2 AND 3 WERE FORMER SMOKERS >40 PACK-YEARS EACH. PT 1 WAS OBESE. PT 1 HAD A TYPE III LEAK DUE TO POOR APPOSITION OF THE LEFT ILIAC LIMB. HE UNDERWENT EMBOLIZATION OF THE MAIN LEFT HYPOGASTRIC ARTERY ON TWO OCCASIONS (COILS AND THE PUSHABLE CORES) BEFORE EXPLANT LATER THE SAME YEAR. NO ANTIBIOTICS WERE GIVEN DURING THIS PROCEDURE. IN PT 2, A TYPE III ENDOLEAK WAS IDENTIFIED AT THE TIME OF INFECTION DIAGNOSIS. AORTIC-ENTERIC FISTULA WAS DISCOVERED IN PTS 3 AND 9. THEY DID PRESENT WITH GI BLEEDING. THE AEF'S WERE DISCOVERED AT EXPLANTATION ONLY AFTER AXILLARY-BIFEMORAL BY-PASS WAS COMPLETED. PT 3 EXPERIENCED EXCESSIVE OPERATIVE BLEEDING AND WAS NOT EXPECTED TO SURVIVE. THEY WERE PACKED, CLOSED AND TRANSFERRED TO THE INTENSIVE CARE UNIT, WHERE THEY DIED WITHIN HOURS. PT 3 WAS IN HEMORRHAGIC SHOCK DUE TO AN UNIDENTIFIED SOURCE OF BLEEDING AND CARDIAC ARRESTED SEVERAL TIMES INTRAOPERATIVELY. PT 1 AND 9 UNDERWENT TAGGED LEUKOCYTE SCANS TO CONFIRM SUSPICION OF NOTED ON CT; UPTAKE WAS VISUALIZED IN THE AORTIC LUMEN, "ANEURYSM SAC ADJACENT TO ENDOGRAFT," AND FLUID COLLECTION ANTERIOR TO THE ILIAC BIFURCATION, RESPECTIVELY. ALL GRAFTS WERE EXPLANTED THROUGH A MIDLINE TRANSPERITONEAL BECAUSE THIS IS THE PREFERRED APPROACH OF THE SENIOR AUTHOR. TOTAL EXCISION OF THE ENDOGRAFT WAS PERFORMED IN ALL CASES, OFTEN USING A SUPRARENAL OR SUPRACELIAC CLAMP, EXCEPT IN PT 2 SECONDARY TO OVERALL POOR MEDICAL CONDITION AND WANTING TO AVOID A SUPRARENAL AORTIC CROSS CLAMP. AN AXILLARY-TO=BIFEMORAL BYPASS WAS DONE BEFORE EXPLANTATION IN PTS 3 AND 9, WHEREAS THE OTHER FOUR UNDERWENT SIMULTANEOUS IN SITU GRAFT PLACEMENT. THE AXILLARY-TO-BIFEMORAL BYPASSES WERE PERFORMED WITH POLYTETRAFLUOROETHYLENE THE DAY BEFORE EXPLANTS. COMPLICATIONS DURING THE OPERATIVE PROCEDURE INCLUDED SIGNIFICANT HYPOTENSION REQUIRING CARDIOPULMONARY RESUSCITATION IN PT 3 AFTER FINDING AN AEF DURING EXPLANTATION OF THE ENDOGRAFT. PT 3 HAD BEEN ON INTRAVENOUS AND THEN ORAL ANTIBIOTICS FOR 3 MONTHS BEFORE GRAFT EXPLANTATION. PT 9 HAD BEEN ON INTRAVENOUS ANTIBIOTICS FOR 1 TO 4 WEEKS DUE TO LOCAL ABSCESSES AND FOR TREATING SUSPECTED REMOTE INFECTIONS. PT 3 HAD A LARGE 4-CM DEFECT FOUND IN THE AORTIC WALL AND FOURTH PART OF THE DUODENUM. THE DUODENUM OF PT 9 WAS FOUND DENSELY ADHERENT TO THE ANEURYSM SAC BY THE RETROPERITONEAL ABSCESS. THE EXACT CAUSE OF FISTULA FORMATION IS NOT KNOWN, BUT IS HYPOTHESIZED TO BE DUE TO EROSION OF THE GRAFT FABRIC INTO THE DUODENUM. ALL DEVICES MENTIONED IN THE JOURNAL ARTICLE WERE EXPLANTED DUE TO INFECTIONS. PT 9 ALIVE AT 2 MONTHS POST EXPLANT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY MIH SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH COOK, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention